US11083750B2ActiveUtilityA1

Methods of treatment using topical copper ion formulations

95
Assignee: CDA RES GROUP INCPriority: Mar 15, 2013Filed: Sep 14, 2016Granted: Aug 10, 2021
Est. expiryMar 15, 2033(~6.7 yrs left)· nominal 20-yr term from priority
Inventors:Dominic C. AbbottChunlim Abbott
A61K 9/0031A61K 9/12A61K 8/19A61K 33/34A61K 9/7084A61Q 11/00A61K 9/0043A61K 9/10A61K 9/08A61K 9/122A61K 9/02A01M 31/00A61K 9/0014A61K 9/06A61K 9/0036A61K 9/006A61K 9/0034A61K 9/0046A61Q 17/005
95
PatentIndex Score
10
Cited by
235
References
49
Claims

Abstract

Provided herein are topical formulations containing copper ions and methods of treating inflammatory, microbial, and arthritic conditions in various areas of the body using such formulations. Methods of treating osteoarthritis using topical copper ion treatments are provided. Methods of treating and preventing microbial infections using copper ion treatments are further provided, including methods of preventing biofilm. A topical treatment in its basic form comprises a biocompatible copper ion solution or suspension obtained by leaching of the copper ions from copper metal. The copper ion solution or suspension is combined with various carriers to form the copper ion treatment including creams, gels, lotions, foams, pastes, tampons, solutions, suppositories, body wipes, wound dressings, skin patches, and suture material. Methods of making the copper ion solution or suspension from solid copper metal in a biocompatible solution are also provided.

Claims

exact text as granted — not AI-modified
The invention claimed is: 
     
       1. A pharmaceutically acceptable formulation for use in treating a condition causing pain and/or swelling of a joint of a subject, the pharmaceutically acceptable formulation consisting of:
 (a) a carrier consisting of a liquid phase and a soluble phase, the liquid phase comprising about 5 μg/mL to about 15 μg/mL copper ions; and 
 (b) a copper ion-containing suspension consisting of:
 (i) a saline solution; 
 (ii) one or more buffers; and 
 (iii) copper ions, 
 
 wherein the copper ions are a result of:
 (A) placing a solid copper metal of 99.5% or greater copper content into the saline solution; 
 (B) allowing the solid copper metal to remain in the saline solution for a predetermined period of time; and 
 (C) removing the solid copper metal from the saline solution, thereby disposing the copper ions in the saline solution. 
 
 
     
     
       2. The pharmaceutically acceptable formulation of  claim 1 , wherein the condition is osteoarthritis. 
     
     
       3. The pharmaceutically acceptable formulation of  claim 1 , wherein the joint is a knee, a hip, an elbow, a hand joint, a spine or a toe. 
     
     
       4. The pharmaceutically acceptable formulation of  claim 1 , wherein the joint is a knee joint. 
     
     
       5. The pharmaceutically acceptable formulation of  claim 1 , wherein the subject achieves a VAS score that is at least 15 units lower than a baseline VAS score. 
     
     
       6. The pharmaceutically acceptable formulation of  claim 5 , wherein the subject achieves a VAS score that is at least 25 units lower than the baseline VAS score. 
     
     
       7. The pharmaceutically acceptable formulation of  claim 1 , wherein the subject achieves a WOMAC score that is at least 4 units lower than a baseline WOMAC score. 
     
     
       8. The pharmaceutically acceptable formulation of  claim 1 , wherein the carrier having a liquid phase is selected from the group consisting of a cream base, a lotion base, a gel base, and a foam base. 
     
     
       9. The pharmaceutically acceptable formulation of  claim 8 , wherein the carrier is a cream base. 
     
     
       10. The pharmaceutically acceptable formulation of  claim 9 , wherein the cream base comprises water, emulsifying wax, ethylhexyl stearate, cyclopentasiloxane, sorbitol, tocopheryl acetate, aloe barbadensis leaf juice powder, disodium EDTA, methylchloroisothiazolinone, and methylisothiazolinone. 
     
     
       11. The pharmaceutically acceptable formulation of  claim 1 , wherein the pharmaceutically acceptable formulation comprises at least 10 μg/mL copper ions in the liquid phase. 
     
     
       12. The pharmaceutically acceptable formulation of  claim 1 , wherein the pharmaceutically acceptable formulation comprises about 11.5 μg/mL copper ions in the liquid phase. 
     
     
       13. The pharmaceutically acceptable formulation of  claim 1 , wherein the pharmaceutically acceptable formulation comprises copper ions disposed in a solution as a result of leaching copper ions from a solid copper metal, and wherein the solid copper metal consists of pure copper. 
     
     
       14. The pharmaceutically acceptable formulation of  claim 13 , wherein the pharmaceutically acceptable formulation consists of 5%, 10%, 20%, or 30% of the solution. 
     
     
       15. A method of treating a condition that causes pain and/or swelling of a joint comprising topically administering the pharmaceutically acceptable formulation of  claim 1  1-3 times daily to a human in need of such treatment. 
     
     
       16. The method of  claim 15 , wherein the condition is osteoarthritis. 
     
     
       17. The method of  claim 15 , wherein the joint is a knee, a hip, an elbow, a hand joint, a spine or a toe. 
     
     
       18. The method of  claim 17 , wherein the joint is a knee joint. 
     
     
       19. The method of  claim 15 , wherein the subject achieves a VAS score that is at least 15 units lower than the baseline VAS score. 
     
     
       20. The method of  claim 19 , wherein the subject achieves a VAS score that is at least 25 units lower than the baseline VAS score. 
     
     
       21. The method of  claim 15 , wherein the subject achieves a WOMAC score that is at least 4 units lower than the baseline WOMAC score. 
     
     
       22. The method of  claim 15 , wherein the pharmaceutically acceptable formulation is a cream, lotion, gel or a foam. 
     
     
       23. The method of  claim 22 , wherein the pharmaceutically acceptable formulation is a cream. 
     
     
       24. The method of  claim 23 , wherein the cream is 3VM1001. 
     
     
       25. The method of  claim 22 , wherein the pharmaceutically acceptable formulation comprises at least 10 μg/mL copper ion in the liquid phase. 
     
     
       26. The method of  claim 22 , wherein the pharmaceutically acceptable formulation comprises about 11.5 μg/mL copper ion in the liquid phase. 
     
     
       27. The method of  claim 15 , wherein the pharmaceutically acceptable formulation is administered 1-5 times daily. 
     
     
       28. The method of  claim 27 , wherein the pharmaceutically acceptable formulation is administered 2-3 times daily. 
     
     
       29. The method of  claim 28 , wherein the pharmaceutically acceptable formulation is administered 3 times daily. 
     
     
       30. The method of  claim 15 , wherein 1-10 g of the pharmaceutically acceptable formulation is applied at each administration. 
     
     
       31. The method of  claim 30 , wherein 1-5 g of the pharmaceutically acceptable formulation is applied at each administration. 
     
     
       32. The method of  claim 31 , wherein 1-3 g of the pharmaceutically acceptable formulation is applied at each administration. 
     
     
       33. The method of  claim 32 , wherein 2 g of a pharmaceutically acceptable formulation is applied at each administration. 
     
     
       34. The method of  claim 33 , wherein 2 g of the pharmaceutically acceptable formulation is applied topically 3 times per day. 
     
     
       35. The method of  claim 34 , wherein the pharmaceutically acceptable formulation is a cream. 
     
     
       36. The method of  claim 35 , wherein the cream is 3VM1001. 
     
     
       37. The method of  claim 15 , wherein the pharmaceutically acceptable formulation comprises copper ions disposed in a solution as a result of leaching copper ions from a solid copper metal, and wherein the solid copper metal consists of pure copper. 
     
     
       38. The method of  claim 37 , wherein the pharmaceutically acceptable formulation is a cream, lotion, gel or a foam. 
     
     
       39. The method of  claim 38 , wherein the pharmaceutically acceptable formulation consists of 5%, 10%, 20%, or 30% of the solution. 
     
     
       40. A method of administering the pharmaceutically acceptable formulation of  claim 1  1-5 times daily. 
     
     
       41. The method of  claim 40  wherein the pharmaceutically acceptable formulation is administered 2-3 times daily. 
     
     
       42. The method of  claim 41 , wherein the pharmaceutically acceptable formulation is administered 3 times daily. 
     
     
       43. The method of administering the pharmaceutically acceptable formulation of  claim 1 , wherein 1-10 g of the pharmaceutically acceptable formulation is applied at each administration. 
     
     
       44. The method of  claim 43 , wherein 1-5 g of the pharmaceutically acceptable formulation is applied at each administration. 
     
     
       45. The method of  claim 44 , wherein 1-3 g of the pharmaceutically acceptable formulation is applied at each administration. 
     
     
       46. The method of  claim 45 , wherein 2 g of a pharmaceutically acceptable formulation is applied at each administration. 
     
     
       47. The method of  claim 1 , wherein 2 g of the pharmaceutically acceptable formulation is applied topically 3 times per day. 
     
     
       48. The method of  claim 47 , wherein the pharmaceutically acceptable formulation is a cream. 
     
     
       49. The method of  claim 48 , wherein the cream is 3VM1001.

Cited by (0)

No later patents cite this yet.

References (0)

No backward citations on record.